Symptom Tracking in Assisted Reproductive Technologies (START)

This study is ongoing, but not recruiting participants.

Sponsor:

Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT01746797

First Posted: December 11, 2012

Last Update Posted: June 9, 2017

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This study assesses risk factors for depressive relapse in women undergoing fertility treatment with histories of major depressive disorder (MDD) or bipolar disorder. The study is focused on the acute risk factors of depressive relapse.

The investigators hypothesize that risk for depressive relapse will be greater among women who stop antidepressants compared to those who continue treatment with these agents.

Women who have selected to stay on antidepressant medication while undergoing infertility treatment.

Women not on antidepressants

Women who decided to discontinue their antidepressants while undergoing fertility treatments.

Detailed Description:

This study hopes to address the following aims:

Specific Aim #1: To delineate the relative risk of relapse in women undergoing IVF, IUI, or other infertility treatments who discontinue antidepressant therapy for depression, compared to those who maintain treatment with these agents.

Hypothesis: Risk for depressive relapse will be greater among women who stop antidepressants compared to those who continue treatment with these agents.

Hypothesis: Relapse rates will be greater among those who have: 1) histories of more recurrent depressive illness, 2) longer duration of attempt to conceive, and 3) a lower degree of perceived support from respective partners.

Specific Aim #3 (exploratory): To describe the trajectory of depressive symptoms in women with histories of depression across the course of IVF, IUI, or other treatments.

Hypothesis: Specific phases of the IVF cycle will have differential effects on the burden of depressive symptoms. Specifically, these phases include: 1) the phase prior to egg retrieval, 2) the phase after embryo transfer while a woman waits for the pregnancy test or her menstrual period, and 3) the phase after the experience of a negative pregnancy test (when applicable) following an IVF cycle. We seek to characterize factors associated both with vulnerability to more depressive symptoms and to resilience in the context of the different phases of IVF treatment.

Hypothesis: Hypothalamic-pituitary-adrenal (HPA) axis dysregulation, evidenced by increases in diurnal salivary cortisol patterns and markers of inflammation, will be associated with higher

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

Subjects will include 60 women 18 years and older with histories of depression or bipolar disorder who are planning infertility treatment, specifically in utero insemination (IUI) or in vitro fertilization (IVF).

Criteria

Inclusion Criteria:

Have a history of a MDE or bipolar disorder prior to starting fertility treatment.

Have received consultation around infertility treatment and plan to start fertility treatment.

Exclusion Criteria:

Use of corticosteroids within 1 month of enrollment.

Presence of any endocrine or autoimmune disorder, other than hypothyroidism well-treated for at least 6 months.

Current episode of depression or mania.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746797